Erik Larsen, MA

GLP Quality Assurance Lead

Erik Larsen, BA, MA, is a highly regarded expert and leader in the areas of GLP, GCP, Bioanalytical and Quality Assurance with experience in Computer Systems support for regulated operations. Erik has over 46 years’ experience in the pharmaceutical industry including  management of Global Quality Teams (Upjohn, Pharmacia & Upjohn, Pharmacia, and Pfizer), cross-functional auditing in 12 countries and multiple GxP disciplines, regulatory inspection conduct & management, Quality Systems implementation, global submission requirements and applications, Animal Welfare program evaluations, and conducting small molecule pre-clinical GLP toxicology studies.

For the last 14 years, Erik has provided consulting services to a variety of large pharma and biotechnology companies, as well as contract research organizations throughout the US and overseas to improve their Quality programs, inspection readiness, and training programs. He has also been involved in and had a leadership role in a project to evaluate Clinical Development operations and the conduct of Bioanalytical remediation at a mid-size pharma company. He is well known for his vast knowledge of US and international regulatory requirements and his risk-based, strategic approach to evaluating QA programs to improve processes and to assure regulatory compliance for his clients.